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aripiprazole

Abilify, Abilify Maintena · ATC code N05AX12

Also known as: Aripiprazol · Brand names: Abilify, Abilify Maintena, 300, Arileto, Aripipan, Aripiprazole Abz, Arpoya, Aryfrenix, Aryzalera, Abizol, Aripa, Arpada, Fixment, Ignis, Madepzol …

Key facts
Active substance
aripiprazole
Drug class
Antipsychotics
ATC code
N05AX12
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ABILIFY 5 mg tablets / ABILIFY 10 mg tablets / ABILIFY 15 mg tablets · ABILIFY 10 mg orodispersible tablets / ABILIFY 15 mg orodispersible tablets / ABILIFY 30 mg orodispersible tablets · ABILIFY 1 mg/mL oral solution · ABILIFY 7.5 mg/mL solution for injection · Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection / Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection / Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- · Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe / Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe
Marketing authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
Information as of
2026-10-27

Key facts

Aripiprazole is an antipsychotic. It is used for schizophrenia and manic episodes in bipolar I disorder; as a depot injection (Abilify Maintena) for maintenance treatment of schizophrenia.

What it is used for

  • Abilify oral: schizophrenia in adults and adolescents aged 15 years and older
  • Abilify oral: moderate to severe manic episodes in bipolar I disorder and prevention of new manic episodes in adults; up to 12 weeks in adolescents aged 13 and older
  • Abilify solution for injection: rapid control of agitation in schizophrenia or mania when oral therapy is not appropriate
  • Abilify Maintena: maintenance treatment of schizophrenia in adults stabilised with aripiprazole

Dosing

  • Abilify oral, schizophrenia (adults): start 10 mg/day or 15 mg/day, maintenance 15 mg/day once daily; maximum 30 mg/day
  • Abilify oral, mania: start 15 mg once daily; maximum 30 mg/day
  • Adolescents 15 years and older (schizophrenia): 10 mg/day after titration via 2 mg and 5 mg
  • Abilify solution for injection: 9.75 mg intramuscularly, range 5.25 mg to 15 mg per injection
  • Abilify Maintena 400 mg: 400 mg once monthly after a one- or two-injection start with oral aripiprazole
  • With strong CYP2D6 inhibitors (e.g. quinidine) reduce the oral dose to approximately one-half; further regimens (e.g. 960 mg every 2 months) in the full product information

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Suicidal behaviour, sometimes early after starting or switching; closely supervise high-risk patients
  • Elderly patients with dementia-related psychosis: increased mortality
  • Caution in cardiovascular and cerebrovascular disease; venous thromboembolism with antipsychotics
  • Gambling disorder and other impulse control disorders may occur
  • Abilify Maintena not for acutely agitated or severely psychotic states

Side effects

  • Oral: most common akathisia and nausea (each in more than 3%)
  • Abilify Maintena: weight increased (9.0%), akathisia (7.9%), insomnia (5.8%), injection site pain (5.1%)
  • Others: leukopenia, neutropenia, allergic reactions

Interactions

  • Strong CYP2D6 inhibitors (quinidine, fluoxetine, paroxetine) and CYP3A4 inhibitors raise aripiprazole levels; reduce dose
  • May enhance the effect of certain antihypertensives
  • Caution with alcohol, other CNS medicines and QT-prolonging drugs

Pregnancy and breastfeeding

  • Inadequate data; use in pregnancy only if the expected benefit clearly justifies the potential risk to the foetus
  • Abilify Maintena: exposure after a single dose may remain for up to 34 weeks; in women planning pregnancy only if clearly necessary

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • 3001a Pharma Gmbh · 1 register entry
  • AriletoG.L. Pharma Gmbh · 1 register entry
  • Aripiprazol1a Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Teva B.V, Genericon Pharma Gesellschaft M.B.H., +pharma Arzneimittel Gmbh, Aristo Pharma Gmbh (Art 57), Sandoz Gmbh, Stada Arzneimittel Gmbh, Krka, D.D., Novo Mesto · 10 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • AripipanTad Pharma Gmbh · 1 register entry
  • Aripiprazol1 A Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Aaa-Pharma Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Hec Pharm Gmbh, Medical Valley Invest Ab, Glenmark Arzneimittel Gmbh, Glenmark Pharmaceuticals S.R.O., Hormosan Pharma Gmbh, Axcount Generika Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Amarox Pharma Gmbh, Ascend Gmbh, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Tad Pharma Gmbh, Kohlpharma Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 29 register entries
  • Aripiprazole AbzAbz-Pharma Gmbh · 1 register entry
  • ArpoyaHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • AryfrenixPuren Pharma Gmbh & Co. Kg · 1 register entry
  • AryzaleraKrka, D.D., Novo Mesto · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AbilifyABDİ İBRAHİM OTSUKA İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • AbizolNOBEL İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
  • AripaALİ RAİF İLAÇ SAN. A.Ş. · 13 register entries
  • ArpadaWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • FixmentNEUTEC İLAÇ SAN. TİC. A.Ş · 3 register entries
  • IgnisSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 12 register entries
  • MadepzolNOBEL SAĞLIK ÜRÜNLERİ LTD ŞTİ · 5 register entries
  • OryvaGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 5 register entries
  • ParokzolHUMANİS SAĞLIK A.Ş. · 4 register entries
  • Rima-FixNEUTEC İLAÇ SAN. TİC. A.Ş · 6 register entries
  • RipazolGENVEON İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
  • SayfrenSANTA FARMA İLAÇ SAN. A.Ş. · 1 register entry
Show all 14 brand names
  • ValdezolASET İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • ZoleripTEVA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 28 more European countries
Belgium
Aripiprazol Krka, Aripiprazol Sandoz, Aripiprazole Ab, Aripiprazole Eg, Aripiprazole Teva, Tractiva
Bulgaria
Абизол, Арикоган, Ариспа, Експлемед, Зикалор, Рестигулин
Croatia
Aregzilap, Aripiprazol Pliva, Aripiprazol Stada, Arisppa, Azivertam, Azolar, Zykalor
Cyprus
Aripiprazole Aurobindo, Aripiprazole Krka, Aripiprazole Stada, Elxeda, Pirazol, Zykalor
Czechia
Abyca, Aricogan, Aripiprazol +pharma, Aripiprazol Teva, Aripiprazole Neuraxpharm, Aripiprazole Teva, Aryzalera, Asduter, Explemed, Restigulin, Tractiva, Zykalor
Denmark
Aripiprazol Krka, Aripiprazol Stada, Aripiprazole "hexal", Aripiprazole Medical Valley, Aripiprazole Stada, Aripiprazole Teva, Arpoya
Estonia
Aregzilap, Aripiprazole Stada, Arisppa, Zykalor
Finland
Aripiprazol Krka, Aripiprazol Stada, Aripiprazole Hexal, Aripiprazole Orion, Aripiprazole Ratiopharm, Aripiprazole Stada
France
Aripiprazole Almus, Aripiprazole Arrow, Aripiprazole Bgr, Aripiprazole Biogaran, Aripiprazole Cristers, Aripiprazole Eg, Aripiprazole Evolugen, Aripiprazole Hec Pharm, Aripiprazole Krka, Aripiprazole Sandoz, Aripiprazole Teva, Aripiprazole Viatris, Aripiprazole Zydus
Greece
Abelfiz, Aripility, Aripiprazole Genepharm, Aripiprazole Stada, Aripral, Arisppa, Arpilif, Arpoya, Epimat, Lipahar, Memogalin, Prazarit, Rapiproz, Zykalor
Hungary
Aripiprazol Sandoz, Aripiprazol Stada, Aripiprazol Teva, Aripiprazole Abartis, Aripiprazole Teva, Arisppa, Asduter, Explemed, Kamidam, Restigulin
Iceland
Abilify, Aripiprazol Accord Healthcare, Aripiprazol Krka, Aripiprazol W&h, Aripiprazole Accord, Aripiprazole Hexal, Aripiprazole Medical Valley, Aripiprazole Mylan Pharma, Aripiprazole Sandoz, Aripiprazole Zentiva, Tractiva
Ireland
Aripiprazole Brillpharma (Ireland), Aripiprazole Clonmel, Aripiprazole Krka, Aripiprazole Pinewood Laboratories, Aripiprazole Teva, Aripiprazole Universal Farma
Italy
Aberipra, Aripiprazolo Alter, Aripiprazolo Aurobindo, Aripiprazolo Doc, Aripiprazolo Eg, Aripiprazolo Krka, Aripiprazolo Laboratori Alter, Aripiprazolo Mylan Generics, Aripiprazolo Mylan Italia, Aripiprazolo Olpha, Aripiprazolo Sandoz Bv, Aripiprazolo Teva, Arpoya, Tractiva
Latvia
Aregzilap, Aripiprazole Acino, Aripiprazole Stada, Arisppa, Azivertam, Zykalor
Liechtenstein
Abilify, Aripiprazole Accord, Aripiprazole Mylan Pharma, Aripiprazole Sandoz, Aripiprazole Zentiva
Lithuania
Aregzilap, Aripiprazole Stada, Arisppa, Zykalor
Luxembourg
Aripiprazol Ratiopharm, Aripiprazole Eg, Tractiva
Malta
Aripiprazole Ascend, Aripiprazole Clonmel, Aripiprazole Doc, Aripiprazole Normon, Arisppa, Zykalor
Netherlands
Aribit Odt, Aricogan, Aripiprazol Amarox, Aripiprazol Brillpharma, Aripiprazol Cf, Aripiprazol Doc Generici, Aripiprazol Genthon, Aripiprazol Gloramp, Aripiprazol Krka, Aripiprazol Laboratorios Liconsa, Aripiprazol Prolepha, Aripiprazol Sandoz, Aripiprazol Synthon, Aripiprazol Teva, Aripiprazol Xiromed, Aripiprazole Aurobindo
Norway
Abilify, Aripiprazol Stada, Aripiprazole Accord, Aripiprazole Hexal, Aripiprazole Medical Valley, Aripiprazole Mylan Pharma, Aripiprazole Sandoz, Aripiprazole Stada, Aripiprazole Zentiva
Poland
Abilium, Apiprax, Apra, Aribit, Aricogan, Aripilek, Aripiprazole +pharma, Aripiprazole Medical Valley, Aripiprazole Orion, Arpixor, Aryfrenix, Arypiprazol Glenmark, Aryzalera, Asduter, Explemed, Tractiva
Portugal
Aripiprazol Altedron, Aripiprazol Alter, Aripiprazol Aurovitas, Aripiprazol Bluepharma, Aripiprazol Bluesar, Aripiprazol Ciclum, Aripiprazol Farmoz, Aripiprazol Generis, Aripiprazol Krka, Aripiprazol Mylan Pharma, Aripiprazol Pentafarma, Aripiprazol Pharmakern, Aripiprazol Sandoz, Aripiprazol Tetrafarma, Aripiprazol Teva, Aripiprazol Tolife, Aripiprazol Vitória, Arpixor, Aryfrenix, Epimat, Zalonil, Zykalor
Romania
Aripiprazol Accord Healthcare, Aripiprazol Stada, Aripiprazol Teva, Aryzalera, Astoret, Lemilvo, Zykalor
Slovakia
Aripiprazol Sandoz, Aripiprazol Stada, Aripiprazol Teva, Aripiprazol Viatris, Arisppa, Asduter, Lemilvo
Slovenia
Aripiprazol Accord Healthcare, Aripiprazol Stada, Aryzalera, Lemilvo, Tablete Accord Healthcare, Zykalor
Spain
Abik, Abilium, Abipol, Akitex, Apaloz, Apazol, Aripiprazol Almus, Aripiprazol Alter, Aripiprazol Aurovitas, Aripiprazol Cinfa, Aripiprazol Combix, Aripiprazol Flas Cinfa, Aripiprazol Flas Sandoz, Aripiprazol Flas Stada, Aripiprazol Krka, Aripiprazol Laboratorios Liconsa, Aripiprazol Liconsa, Aripiprazol Mabo, Aripiprazol Medsolutions (Europe), Aripiprazol Normon, Aripiprazol Olpha, Aripiprazol Pensa, Aripiprazol Qualigen, Aripiprazol Ratiopharm, Aripiprazol Stada, Aripiprazol Tad, Aripiprazol Tarbis, Aripiprazol Tecnigen, Aripiprazol Teva-Ratiopharm, Aripiprazol Tevagen, Aripiprazol Vir, Arizol, Atildon Flas, Mentrova, Tractiva, Xerana, Zykalor
Sweden
Aregzilap, Aripiprazol Krka, Aripiprazol Stada, Aripiprazole, Lipahar

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Abilify – EPAR, Product Information (OF THE TEXT {MM/YYYY} Detailed information on this medicinal). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/abilify-epar-product-information_en.pdf
  2. European Medicines Agency. Abilify Maintena – EPAR, Product Information (OF THE TEXT MM/YYYY Detailed information on this medicinal p). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/abilify-maintena-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC N05AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.